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NCT Number: NCT06562335

The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy

The goal of this experimental study is to learn if the Booster intervention can be used as an early intervention for persistent fatigue. The aim of the intervention is to prevent more fatigue-related disabilities in young people with chronic illnesses like inflammatory bowel disease, childhood cancer, and juvenile idiopathic arthritis by improving self-confidence in managing fatigue (fatigue-related self-efficacy or FSE).

The main questions this study aims to answer are:

* What is the effect of the Booster intervention on fatigue-related self-efficacy (FSE)? * What is the effect of the Booster intervention on fatigue levels, school participation, life satisfaction, and perceived health? * When does improvement in study outcomes happen relative to the Booster intervention? * What participant characteristics predict change in study outcomes?

Participants will follow the Booster intervention. Booster is a personalised, blended care intervention designed to help young people understand how their thoughts, feelings, and activities impact their fatigue using a smartphone app. The Booster app uses experience sampling methodology (ESM) to track these fluctuations. Based on insights obtained from these data, the participant and their healthcare provider can set personal lifestyle goals, such as increasing physical activity and reducing daytime naps. An earlier version of this intervention, called PROfeel, was effective in reducing severe fatigue. The investigators have now improved the app to also help with setting and achieving personal goals and monitoring daily progress.

The investigators will measure the effect of Booster through daily questionnaires during two phases: Phase A (baseline, before the goal setting between patient and healthcare provider) and Phase B (intervention, starting in the lifestyle change period). The duration of Phase A will be randomised for each participant.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilhelmina Children's Hospital, University Medical Centre Utrecht

Utrecht, Netherlands

Location contact

MD Stutvoet, Msc, M.D.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Experiencing fatigue for at least 3 months and feeling hindered by it (Pediatric Short Fatigue Questionnaire (pSFQ) score of 15 or higher)
  • Diagnosed with a chronic health condition or treated for childhood cancer

Exclusion criteria

Regarding other treatments:

  • Fatigue fully explained by a somatic or psychiatric diagnosis
  • Chronic health condition unstable in the last 3 months (e.g., recent medication changes or cancer relapse)
  • Significant functional limitations due to fatigue (e.g., more than 50% school absenteeism)

Regarding feasibility:

  • Cognitive impairment with an estimated IQ of below 70
  • No smartphone with internet access
  • Unable to speak, read, understand, or write Dutch

Treatment and study plan

Booster

Other

See description of arm. The Booster intervention has evolved from the PROfeel intervention. PROfeel is described in: https://doi.org/10.1186/s13063-022-06620-2

Other names: PROfeel

Primary outcomes

  1. Fatigue-related self-efficacy

    Time frame: Daily before and during the intervention, for approximately 130 days

    Single-item question, self-report via Booster app. The single item was designed and validated for this study. Answered on a VAS scale 0 to 100. Higher score represents higher fatigue-related self-efficacy.

Secondary outcomes

  1. Fatigue severity

    Time frame: Daily before and during the intervention, for approximately 130 days

    pediatric short fatigue questionnaire, 4-item questionnaire, answered on a seven point Likert scale (1 = yes that is true, 7=no, that is not true). Total score ranges from 4 to 28, with higher scores reflecting more fatigue.

  2. Participation

    Time frame: Daily before and during the intervention, for approximately 130 days

    School or work presence. Calculated: (hours present/the hours scheduled)*100

  3. Life satisfaction

    Time frame: Daily before and during the intervention, for approximately 130 days

    Cantril Ladder, single-item question, rate life with ladder numbered from 0 to 10. Top of the ladder (10) represents the best possible life. The bottom (0) represents the worst possible life.

  4. Perceived health

    Time frame: Daily before and during the intervention, for approximately 130 days

    EuroQol (EQ) visual analogue scale (VAS), ranging from 0 (worst health you can imagine) to 100 (best health you can imagine).

Other outcomes

  1. Fatigue-related self-efficacy

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Self-Efficacy Scale-28 (SES-28) , 7-item questionnaire answered on a four-point likert scale, total scores range from 7 to 28 with higher scores indicating higher sense of control over fatigue.

  2. Fatigue

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    PEDsQL-MFS, 23-item questionnaire

  3. Fatigue

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PEDsQL-MFS), 24-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 96, with higher scores representing more fatigue.

  4. Health-related quality of life

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Pediatric Quality of Life Inventory-Generic Core Scales (PEDsQL-GCS), a 23-item questionnaire answered on a five-point likert (0=never, 4 = almost always), total score ranging from 0 to 92, with higher scores representing higher quality of life. The questionnaire has the following subscales: physical, emotional, social and school or work functioning.

  5. Health-related quality of life

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Child Health Utility Index 9D (Chu9d), nine-item questionnaire answered on a five-point likert (0 to 4), total score ranging from 0 to 36, higher scores representing lower quality of life. The Chu9D has utility values that enable calculating quality adjusted life years.

  6. Health-related quality of life

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    EuroQol Five Dimensions Health Questionnaire Youth (EQ-5D-Y-3L), five-item questionnaire answered on a three point likert (no problems (1), some problems(2), a lot of problems(3)), total score ranging from 5 to 15, higher scores representing lower quality of life. The EQ-5D-Y-3L has utility values that enable calculating quality adjusted life years.

  7. School or work absence

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Single item question on average absence over past half a year in %

  8. Illness identity - fatigue

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Illness identity questionnaire (ILQ), a 25-item questionnaire, answered on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has the following subscales: engulfment (8 items, range 8 to 40), rejection (5 items, range 5 to 25), acceptance (5 items, range 5 to 25) and enrichment (7 items, range 7 to 35). Higher scores on subscales represent respectively higher engulfment, rejection, acceptance and enrichment. The questionnaire is adapted to specifically ask for illness identity regarding fatigue (e.g., I refuse to see my fatigue as part of myself)

  9. Mastery

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Pearlin Schooler Mastery Scale, a seven-item questionnaire, answered on a four-point Likert scale, ranging from strongly disagree (1) to strongly agree (4). Total score ranges from 7 to 28, with higher scores reflecting higher levels of mastery.

  10. Physical activity

    Time frame: Baseline, 3 months, 6 months, and if interim analysis show medium to large change also at 12 months

    Physical Activity Questionnaire for Adolescents (PAQ-A), a nine-item questionnaire. The first eight items are answered on a five-point Likert scale, ranging from low (1) to high (5) levels of physical activity. The ninth item asks whether the past week's activity was typical, less than typical, or more than typical, to provide context for the responses.The total score is calculated by averaging the scores of the first 8 items, yielding a final score ranging from 1 to 5. Higher scores indicate higher levels of physical activity.

Study contacts

Contact information is provided by the study sponsor or research team.

A Vroegindeweij, MSC

CONTACT

+3188 755 5555

MD Stutvoet, MSC, M.D.

CONTACT

[email protected]

+3188 755 5555

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Netherlands Organisation for Scientific Research

Registry information

Official study title

Blended Therapy for Youth With a Chronic Health Condition to Increase Fatigue-related Self-efficacy (Booster): Protocol for a Multiple Baseline Single Case Experimental Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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